Paralyzed Jockey Loses Ability to Walk After Manufacturer Refuses to Fix Battery For His $100,000 Exoskeleton
Paralyzed Jockey Loses Ability to Walk After Manufacturer Refuses to Fix Battery For His $100,000 Exoskeleton
Michael Straight learned to walk again with the help of an exoskeleton. After an accessory to the device broke, the company refused to fix it.
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Trained repair professionals at hospitals are regularly unable to fix medical devices because of manufacturer lockout codes or the inability to obtain repair parts. During the early days of the COVID-19 pandemic, broken ventilators sat unrepaired for weeks or months as manufacturers were overwhelmed with repair requests and independent repair professionals were locked out of them. At the time, I reported that independent repair techs had resorted to creating DIY dongles loaded with jailbroken Ukrainian firmware to fix ventilators without manufacturer permission. Medical device manufacturers also threatened iFixit because it posted ventilator repair manuals on its website. I have also written about people with sleep apnea who have hacked their CPAP machines to improve their basic functionality and to repair them.
PS: he got it repaired.
The manufacture should have zero say if their product gets repaired or not. The only person who can give permission to repair it is the owner. It should be illegal to implement tying to lockout parts being used as a replacement. Right to repair
They call it jailbreak because this is an issue of freedom: software freedom
Keeping repairs locked into your system of parts/techs can at least feign “safety” or “quality”.
But essentially just refusing to repair is an absolute fuck you.
I’ve started choosing the companies I use based much more on the experience offered when their product/service DOESN’T work, rather than when it does.
A right to repair is long overdue but more than that when it comes to medical devices it's obvious battery replacement is going to be necessary and should be user accessible.
Corporations are a fucking curse.
any company who locks medical device repair should be burned to the ground. and dont bullshit me about liabilities bla it is more likely cash grab which they get in the form of "extra care packages" or exorbitant repair prices charged after the guarantee period ends.
Update: He temporarily gained the ability to walk again after touching a spinning steel ball, despite the recovery not lasting he will still be competing in upcoming cross country horse race.
there is absolutely no excuse for this
Right to repair NOW!
Medical devices should be either supported for life (with money on escrow to support it) or provided with all schematics, manuals and spare parts
Non paywalled article
Line must go 🆙
The CPAP lockout is something I went through. The company behind my CPAP does not allow you to get ANYTHING off the device. But there is an SD Card that you can get all the info you want from your old system. Its arbitrarily locked out.
You are also unable to repair anything on the device without insurance getting involved. And insurance is often at OEM prices (think 200+ for a basic mask). Thankfully, people have illegally added STLs/chips/parts/etc... online that you can basically reverse engineer the entire device nowadays. As long as you use medical safe materials, it saves you literally thousands of dollars. Ive replaced quite a few parts and the device is still working after many years of usage.
Medical devices are required to comply with 21 CFR 820 in the United States, which establishes quality management standards. This includes minimum standards for the software development lifecycle, including software verification and validation testing.
In the EU, broadly equivalent standards include ISO 13485 and IEC 62304.
If an OEM wants to do a software update, they at minimum need to perform and document a change impact analysis, verification testing, and regression testing. Bigger changes can involve a new FDA submission process.
If you go around hacking new software features into your medical device, you are almost certainly not doing all of that stuff. That doesn't mean that your software changes are low quality--maybe, maybe not. But it would be completely unfair to hold your device to the standard that the FDA holds them to--that medical devices in the United States are safe and effective treatments for diseases.
This may be okay if you want to hack your own CPAP (usually a class II device) and never sell it to someone else. But I think we all need to acknowledge that there are some serious risks here.
Louis Rossmann should definitely get right on this case ASAP.
I agree, 404 is legit journalism. No org is perfect, but they're as good as it gets.
Lawmaker, how do you fix this?
